A Study of the Efficacy and Safety of EUFLEXXA™ for Treatment of Painful Osteoarthritis of the Knee

NACompletedINTERVENTIONAL
Enrollment

588

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

December 31, 2007

Study Completion Date

May 31, 2008

Conditions
Osteoarthritis, Knee
Interventions
DEVICE

EUFLEXXA™

EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate (molecular weight 2.4-3.6 MD); sodium chloride, 17 mg; disodium hydrogen phosphate dodecahydrate, 1.12 mg; sodium dihydrogen phosphate dihydrate, 0.1 mg; enough water for injection to make 2.0 ml. EUFLEXXA™ is supplied in 2.25 ml nominal volume, disposable prefilled glass syringes containing 2 mL of EUFLEXXA™. Only the contents of the syringe are sterile. EUFLEXXA™ is nonpyrogenic. See package insert for further details.

DEVICE

placebo

Placebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Only the contents of the syringe are sterile.

Trial Locations (1)

90025-1670

Investigational site, Los Angeles

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY